Kornimate/medical-research-clean huggingface dataset:
visually enhanced education about prostate cancer

Conditions: Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Summary: this randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.

primary objectives: i. our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. of note, the attending radiation oncologist will be responsible for reviewing the powerpoint presentation with the patient, taking time to answer any questions that the patient has outline: patients are randomized into 1 of 2 arms. arm a (standard education): patients receive a standard prostate cancer radiation oncology consultation. arm b (visual enhanced education): patients receive a visually enhanced prostate cancer educational powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.

Eligibility criteria:
inclusion criteria: * patient must have non-metastatic, biopsy proven prostate cancer * must be referred to radiation oncology clinic exclusion criteria: * prior surgery or radiation therapy for prostate cancer * patients who are blind are excluded
perinatal covid-19 infection, no pathway, and minipuberty

Conditions: Newborn, Infant, Disease; Neurodevelopmental Disorders

Summary: some evidence exists that sars-cov-2 may infect pituitary axis, and therefore may alter hypothalamic function. whether perinatal covid-19 is associated with alterations in the maturation of the hypothalamic-pituitary-gonadal (hpg) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. among the various pathogenic features related to covid-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. altered minipuberty together with no deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth


Eligibility criteria:
inclusion criteria: * group 1 : newborn infants (24 to 41 weeks gestational age) or young infants (\< 3 months) admitted at the maternity ward or at the department of neonatology at jeanne de flandre hospital, chu of lille with perinatal covid-19 infection defined by: * antenatal covid-19 infection: pregnant women with positive pcr test at any time of the pregnancy; * post-natal covid-19 infection: newborn or young infants (\< 3 months) with positive pcr test in pharynx or stools as part of their treatment. * group 2 : newborn infants (24 to 41 weeks gestational age) or young infants (\< 3 months) admitted at the maternity ward or at the department of neonatology at jeanne de flandre hospital, chu of lille for severe cardiorespiratory diseases requiring inhaled no treatment. * group 3 : the control group without perinatal covid-19 infection and no inhaled no treatment will be matched to the two other groups on age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks), on respiratory failure (yes/no). * no inclusion in another ante- or post-natal trial; * written consents from both parents. * social security affiliation exclusion criteria: * preterm birth less than 24 weeks gestational age. * severe brain lesions: bilateral and extensive periventricular leukomalacia, intracranial hemorrhage grade 3 or 4; * one or both of the parents is unable to read or understand french language, or refuse to participate

Keywords: perinatal covid newborn minipuberty hpg axis nitric oxide neurodevelopmental outcome
post-prostatectomy linac-based ultrahypofractionated radiotherapy for patients with localized prostate cancer

Conditions: SBRT; Radical Prostatectomy

Summary: radical prostatectomy is a common treatment for localized prostate cancer. more than 30% of men who undergo surgery will subsequently develop recurrence, particularly in patients with adverse features where the risk may be even higher. recurrence typically manifests as a rise in serum-level of prostate-specific antigen (psa), referred to as biochemical recurrence. post-operative radiotherapy is a potentially curative option for many patients, as shown in multiple prior randomized studies. a standard course of post-operative radiation requires 6 to 6 and half weeks of treatment, 5 days a week; however, new high-precision radiation techniques with image guidance, termed stereotactic body radiotherapy (sbrt), can deliver an equivalent or higher dose of treatment in 5 visits. our group, amongst others, have demonstrated in previous studies, that the new 5-treatment technique was safe, convenient and effective in patients with intact prostates. currently, limited data exists on this approach after prostatectomy. this study will be one of the first to assess the side effect profile and efficacy of sbrt in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.


Eligibility criteria:
inclusion criteria: * • histologically confirmed diagnosis of adenocarcinoma of the prostate * completed written informed consent * able and willing to complete self report questionnaires * pathologic stage t3 or t4 (without any gross residual disease), nx-0, m0, and/or +ve surgical margins, and/or a rising psa post-radical prostatectomy on at least 2 consecutive measurements exclusion criteria: * • gross residual disease * histological or radiological node +ve (n1) or distant metastases (m1) * prior pelvic radiotherapy * contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease) * hip prosthesis

Keywords: prostate cancer radiation ultrahypofractionated radiotherapy psa rise sbrt
pilot study on the efficacy of pascoflair in an acute stressful situation (tsst)

Conditions: Healthy; Stress

Summary: a randomized, double blind, placebo-controlled pilot study on the efficacy of passiflora incarnata l. in an acute stressful situation

randomized, double-blind, placebo-controlled, single-center study during visit 1 study information and an informed consent form are handed out. after study inclusion on visit 2, participants are assigned to one of two groups at random and receive the test products (either pascoflair® or placebo tablets). the 3rd visit includes the completion of questionnaires regarding wellbeing and the trier social stress test.

Eligibility criteria:
inclusion criteria: * provide written informed consent; * healthy male and female subjects * non-smoker; * age 25 to 45 years; * bmi ≥ 19 to ≤ 30 kg/m2 exclusion criteria: * any known allergies to the test substance; * any known addiction to drugs, alcohol or positive results in the drug screening test; * any serious general illness, ongoing or within the last 12 months; * any febrile illness (\> 24 hrs.) within 7 days prior to treatment; * any antibiotics for the last four weeks before study inclusion; * diabetes mellitus; * known heart disease, hypertension, kidney disease, significant respiratory disease, epilepsy, or rheumatoid arthritis; * known immunologic or infectious disease (e.g. hepatitis, tuberculosis, hiv or aids) which could place the subject at risk or interfere with the accuracy of the study results; * pregnancy or lactating; * current participation or participation in any type of clinical study in the past week; * current or past participation in a tsst study; * employees of the sponsor or the cro; * any other medication that, in the opinion of the investigator is likely to affect their response to treatment; * clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, or haematology as judged by the investigator; * any other condition the investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results.

Keywords: pascoflair tsst passiflora incarnata non smoking male and female volunteers
development of non-invasive prenatal test for microdeletion and other genetic syndromes based on cell free dna

Conditions: Microdeletion Syndromes; Trisomy 21; Trisomy 18; Trisomy 13; Sex Chromosome Abnormalities

Summary: the purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal dna isolated from maternal blood.

the primary purpose of this study is to collect family triads from families affected by a genetic or microdeletion/duplication (md/d) syndrome to further develop non-invasive prenatal testing based on fetal dna isolated from maternal blood. to assist with the development of the test, we will need to collect blood samples from women whose child was diagnosed with a genetic or md/d syndrome, a blood sample from that child as well as a blood sample from their confirmed unaffected siblings. since the test is based on natera's parental support™ technology, buccal or blood samples from the biological fathers will also be requested. a recent abstract from a five year study on prenatal microarray testing revealed that 1.6% of women who present for routine prenatal indications have a positive microarray test. with the frequency of microdeletions and microduplications (md/d) now known to be higher than previously thought, the field is likely to move toward offering invasive testing for microarray abnormalities to all pregnant women. although non-invasive prenatal testing for aneuploidy is now clinically available, it has become clear that non-invasive prenatal testing for md/d is equally important. however, access to these samples is made difficult as the standard of care for offering microarray analysis to all pregnant women will take time to come to fruition. we would like to develop this non-invasive as the standard of care so that less women will have to undergo invasive testing for the diagnosis of microarray abnormalities. thus, there is an unmet need for the development of novel tests that would increase the scope of non-invasive prenatal screening.

Eligibility criteria:
inclusion criteria: * couples who have a child diagnosed with an autosomal chromosome abnormality (e.g. down syndrome, edwards syndrome, patau syndrome). * couples who have a child diagnosed with a sex chromosome abnormality (e.g. turner syndrome, klinefelter syndrome, triple x syndrome, 47, xyy). * couples who have a child diagnosed with a microdeletion/duplication syndrome (a positive microarray test). exclusion criteria: * not an english language or spanish language speaker * genetics report is not available

Keywords: 22q digeorge angelman cri du chat miller dieker 1p36 phelan mcdermid prader willi wolf hirschorn smith magenis trisomy 21 down syndrome trisomy 18 edwards syndrome trisomy 13 patau syndrome monosomy x turner syndrome xxy klinefelter syndrome xxx xyy
clinical investigation of a small aperture extended depth of focus intraocular lens in patients with complex corneas

Conditions: Cataract; Presbyopia; Irregular Astigmatism

Summary: the objective of this study is to evaluate the clinical outcomes of the ic-8 iol implanted in patients with complex corneas after crystalline lens removal.

this is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. the monocular and binocular performance of the subjects will be evaluated. the objective of this study is to evaluate the clinical outcomes of the ic-8 iol implanted in patients with complex corneas after crystalline lens removal. the co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 months postoperative. the primary safety endpoint is best-corrected distance visual acuity at 4-6 months postoperative. the secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 months postoperative.

Eligibility criteria:
inclusion criteria: 1. minimum 22 years of age; 2. able to comprehend and have signed a statement of informed consent; 3. availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s); 4. planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber iol implantation; 5. planned cataract removal or planned clear lens exchange in both eyes 6. potential for postoperative best-corrected distance visual acuity (bcdva) of 20/32 or better after crystalline lens removal; 7. having complex corneas with irregular astigmatism 8. having clear central cornea 9. having best-corrected distance visual acuity (bcdva) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract). exclusion criteria: 1. requiring an ic-8 iol outside the available spherical power range; 2. pharmacologically dilated pupil size less than 6 mm in either eye; 3. preoperative corneal astigmatism \>1.50 diopters in the eye to be implanted with the ic-8 iol; 4. active or recurrent anterior segment pathology; 5. presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol; 6. congenital bilateral cataracts; 7. previous ocular surgery as specified by the protocol; 8. conditions requiring planned ocular surgical intervention; 9. severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication; 10. use of systemic or ocular medications as specified by the protocol; 11. concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit; 12. patient is pregnant or nursing.
pharmacokinetic drug-drug interaction study of dovitinib (tki258) in patients with advanced solid tumors.

Conditions: Advanced Solid Tumors, Excluding Breast Cancer

Summary: this is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (ddi) study to assess the effect of the cyp1a2 inhibitor, fluvoxamine, on the pk of dovitinib in patients with advanced solid tumors, excluding breast cancer. the purpose of this study is to evaluate the effect of a cyp1a2 inhibitor, 100 mg fluvoxamine, on the pk of dovitinib when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. the study will consist of 2 phases: a pharmacokinetic (pk) phase and a clinical treatment phase. the ddi test will be conducted in the pk phase. the ddi test will assess the steady state pk profile of dovitinib when administered alone and in the presence of the cyp1a2 inhibitor, fluvoxamine (auc 0-24h, auc 0-72h and cmax parameters). during the clinical treatment phase patients may continue to receive treatment with tki258 until disease progression (assessed by recist 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility criteria:
inclusion criteria: patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists - ecog performance status 0 or 1 and an anticipated life expectancy of ≥3 months- patient must meet protocol-specific laboratory values exclusion criteria: - patients with brain metastases - patients who have received or who are expected to receive any prohibited medications and therapies - patients who have received cyp1a2 or cyp3a inhibitor medications within 5 days prior to start study treatment or are expected to receive during the first 28 days after starting the study treatment - patients who have received cyp1a2 or cyp3a inducer medications within 30 days prior to start study treatment or are expected to receive during the first 28 days after starting the study treatment - patients who are actively taking antidepressants, benzodiazepines, serotonergic drugs, and/or monoamine oxidase inhibitors (maois) - patients who have not recovered from previous anti-cancer therapies - patient with impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of tki258 - patients who have concurrent severe and/or uncontrolled concomitant medical conditions that could compromise participation in the study - female patients who are pregnant or breast-feeding - fertile males or women not willing to use highly effective methods of contraception - other protocol-defined inclusion/exclusion criteria will apply
transcranial electrical stimulation in the treatment of acute anxiety induced by stressful life events: a pilot study

Conditions: Anxiety

Summary: the investigators examine the efficacy of two different transcranial direct current stimulation (tdcs) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

transcranial direct current stimulation (tdcs) is a novel neuromodulation method that has been observed to be promising in treatment of psychiatric disorders such as depression. nevertheless, knowledge related to the treatment of psychological stress and its main symptom, anxiety, is very scarce. the investigators examine the efficacy of two different transcranial direct current stimulation (tdcs) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

Eligibility criteria:
inclusion criteria: * age 18-65 years * naïve to tdcs * right-handed * impact of event scale scores ≥ 30 exclusion criteria: * metal implants inside skull or eye * severe skin lesions at the electrode placement area * history of epilepsy or previous seizures * pregnant or breast-feeding * pacemaker * history of intracerebral bleeding during the past six months * major psychiatric conditions according to the structured clinical interview for dsm-iv disorders, i.e., lifetime diagnoses of bipolar mood disorder or psychotic disorder * dsm-iv diagnosis for one or more of the following conditions during the past six months: unipolar mood disorder, anxiety disorders, eating disorders, or substance dependence/abuse. * use of psychotropic medication (i.e., antipsychotic and antidepressant medications, mood stabilizers, psychostimulants, hypnotics and tranquilizers) during the past six months
colonoscopy-related pain predicts the treatment response of amitriptyline in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. in practice, ibs was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. visceral hypersensitivity is the major contributing factor of abdominal pain in ibs. accordingly, tricyclic antidepressants (tcas) are widely used for ibs, especially if abdominal pain is a prominent symptom. indeed, meta-analysis also exhibits the clinically significant efficacy of low dose tcas in ibs. nevertheless, over 40% of ibs patients receiving tcas had no improvement in symptoms after treatment. theoretically, if tcas are used for ibs patients with hypersensitivity, its efficacy could be increased. although rectal distension test might be used to identify hypersensitive patients with ibs, it has been used only for clinical research because it is painful for the patient. on the contrary, colonoscopy is frequently performed in ibs patients to rule out organic disease and for the purpose of colorectal cancer screening. in a study by kim and colleagues, ibs patients reported higher pain score after colonoscopy than non-ibs patients. this has prompted the hypothesis that pain scoring during/after colonoscopy could also segregate ibs patients with visceral hypersensitivity showing better treatment response of tca than those without. the aims of the present study were to evaluate the colonoscopy-related pain perception and the treatment response of amitriptyline in ibs patients and to investigate the predictive values of the colonoscopy-related pain scale in identifying ibs patients with a response to amitriptyline treatment.


Eligibility criteria:
inclusion criteria: * patients with ibs according to the rome iii criteria exclusion criteria: * inflammatory bowel disease or malignancy on colonoscopy. * previous abdominal surgery other than appendectomy or cesarean delivery, * major psychiatric disorders or beck depression inventory-ii score of ≥19 * significant cardiopulmonary diseases or any malignancies * taking pain modulators including selective serotonin reuptake inhibitors (ssri) or tricyclic antidepressants * polypectomy during colonoscopy.
effect of timi3 ultrasound on myocardial blow flow in the hibernating myocardium

Conditions: Myocardial Ischemia

Summary: the purpose of this study is to evaluate whether the use application of low frequency ultrasound, administered by the timi3 ultrasound device, increases myocardial blood flow to the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium). the primary endpoint of the trial is to assess the increase in myocardial blood flow from baseline to post timi3 ultrasound treatment in a hypoperfused region of myocardium. positron emission tomography (pet) imaging will be used to noninvasively evaluate cardiac blood flow. the hypothesis is that ultrasound increases blood flow in hibernating myocardium.


Eligibility criteria:
inclusion criteria: * \>/= 18 years * must have reversible resting ischemia, resting non-reversible blood flow defect, or stress-induced ischemia. * females with childbearing potential must not be pregnant at the time of the study * must provide written informed consent exclusion criteria: * unable or unwilling to cooperate with study procedures * currently enrolled in another clinical study for which the follow-up period is not complete

Keywords: hibernating myocardium blood flow ultrasound pet imaging